Regulatory Submissions & Contract Specialist (Home-Based, Estonia)

About the role

Medpace, a full-service clinical contract research organization, is looking for a full-time, home-based Regulatory Submissions Coordinator and Contract Specialist to join its Clinical Operations team in Estonia. The dual role covers regulatory submissions and contract negotiations, with mentorship and support as you develop your skills and build a career in clinical research.

Key responsibilities

• Prepare, review and file initial clinical trial applications with Estonian regulatory authorities and ethics committees, and prepare responses to queries and amendments
• Ensure submissions comply with applicable regulations and guidance, and advise colleagues on changing regulations
• Maintain the Clinical Trial Management System and ensure timely filing of documents
• Gather documents and prepare submission packages for drug release
• Draft, review, negotiate and finalize agreements, termination letters and other legal documents for clinical studies
• Assess legal, financial and operational risks and escalate them to the Contract Lead or Contract Manager, offering alternatives during negotiations
• Coordinate with internal departments so site startup activities follow the contractual process and agreed timelines

Required profile

• Bachelor's degree (Life Sciences, Business or Law preferred)
• Experience preparing and submitting regulatory documentation to ethics committees and regulatory agencies, including responses to queries
• Experience at a CRO, pharmaceutical company or investigative site
• Knowledge of local regulatory guidelines and legislation
• Fluent in Estonian and English; applications must be submitted in English

Required skills

• Microsoft Office
• Excellent organizational and prioritization skills, able to work independently
• Attention to detail and strong oral and written communication

What we offer

• Competitive compensation and comprehensive health, wellness, retirement and PTO benefits
• Office-based culture with occasional WFH for eligible positions after training
• On-site mentors, defined career paths and onboarding and training programs